The present invention is directed at compositions and products, and methods of making and administering such compositions and products, including for the treatment of mammals and particularly humans.
Bioactive agents, such as peptides, frequently suffer from poor stability, particularly thermo-stability, which may limit the conditions to which the agents can be subjected during preparation, processing, storage and/or delivery. For example, insulin is widely-used in the control and treatment of, e.g., Type 1 & Type 2 diabetes mellitus. Medical preparations of insulin for human use are generally formulated with one or more preservatives and/or stabilisers. Moreover, limited gastrointestinal stability typically presents a barrier to effective oral administration of bioactive peptides, such as insulin.
Bioactive agents such as peptide hormones frequently exhibit sub-optimal pharmacokinetic and/or pharmacodynamic properties when administered by conventional methods and delivery systems. Moreover, administration of combinations of bioactive agents is significantly complicated by varying, and often poorly-matched, pharmacokinetic and/or pharmacodynamic profiles of each of the individual actives that make up the combination.
There remains an unmet need for compositions for delivery of combinations of bioactive peptides that exhibit a more desirable treatment profile.